Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 3:23 AM
Ignite Modification Date: 2025-12-26 @ 2:03 AM
NCT ID: NCT03567005
Description: Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects/eyes that were exposed to any study lenses in the study (Safety Analysis Set), based on treatment-specific exposure.
Frequency Threshold: 5
Time Frame: Dispense through study completion, an average of 14 days
Study: NCT03567005
Study Brief: Clinical Validation of DACP Digital Design
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DACP Digital All subjects exposed to nelfilcon A digital contact lenses 0 None 0 60 0 60 View
DACP All subjects exposed to nelfilcon A contact lenses 0 None 0 60 0 60 View
Serious Events(If Any):
Other Events(If Any):